- Fibrocell will attain approximately $135 million, with approximately $30 million in upfront, development and near-term payments and a 30 percent gross earnings share.
- Fibrocell holds rights to the qualified Rare Pediatric Disease Priority Review Voucher.
- Phase 3 clinical trial initiation predicted in Q2 of 2019.
Fibrocell Science, Inc., a gene and cell therapy firm targeting transformational autologous cell-based treatments for connective tissue and skin ailments, has reportedly declared the conclusion of a partnership contract with Castle Creek Pharmaceuticals to produce and market FCX-007, Fibrocell’s foremost gene therapy candidate, for curing recessive dystrophic epidermolysis bullosa, a rare genetic disorder detected at infancy with no treatment validated by the United States Food and Drug Administration.
According to a press release by the Fibrocell, Castle Creek Pharmaceuticals would attain an exclusive license to market FCX-007 in the US, based on the terms of the partnership contract. Also, Castle Creek Pharmaceuticals would take care of all development and production costs up to $20 Mn before the preliminary Biologics License Application filing with the Food and Drug Administration. In case the development expenditure surpasses $20 million, the company will take care of the 70 percent of the excess spending and Fibrocell will be responsible for 30 percent of such expenses, states the press release.
Reportedly, Fibrocell will obtain an upfront payment of $7.5 Mn, $2.5 Mn for the first candidate registered in the Phase III clinical trial and $30 Mn once it gets approval from the BLA and is commercially ready.
According to sources close to the development, Fibrocell is entitled to receive up to $75 Mn upon attaining sales milestones, comprising $25 Mn upon FCX-007 achieving $250 Mn in cumulative net sales and extra $50 million on achieving $750 Mn in cumulative net sales.
John Maslowski, CEO and President, Fibrocell, stated the company is proud to collaborate with Castle Creek Pharmaceuticals, and this agreement offers non-dilutive capital and resources to continue the development, as well as, if authorized, commercialize FCX-007, a considerably transformative treatment for patients with RDEB.